94
Participants
Start Date
April 3, 2018
Primary Completion Date
March 16, 2020
Study Completion Date
March 16, 2020
Ceftolozane/Tazobactam
Ceftolozane 20 mg/kg (maximum 1 g) and tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 5 to 14 days.
Metronidazole
Metronidazole 10 mg/kg (maximum 1.5 g/day) administered IV every 8 hours for between 5 to 14 days. Participants ≤ 28 days old, start with a loading dose of 15 mg/kg; then if ≤ 2 kg are dosed 7.5 mg/kg/ every 12 hours; or if \> 2 kg are dosed 10 mg/kg every 8 hours.
Meropenem
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days.
Placebo for Metronidazole
Placebo for metronidazole administered IV every 8 hours for between 5 to 14 days.
Semmelweis Egyetem ( Site 0807), Budapest
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0806), Budapest
Debreceni Egyetem Klinikai Kozpont ( Site 0801), Debrecen
SzSzBMK es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz ( Site 0804), Nyíregyháza
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0802), Szeged
PTE AOK Klinikai Kozpont ( Site 0805), Pécs
Red Cross War Memorial Children's Hospital ( Site 1902), Cape Town
Hospital Pulau Pinang ( Site 1102), George Town
SUNY Upstate Medical University Hospital ( Site 2509), Syracuse
Hospital Clinico Universitario de Santiago ( Site 2001), Santiago de Compostela
Vinnytsya Regional Children Clinical Hospital ( Site 2463), Vinnytsia
Eskisehir Osmangazi Unv. Tip Fakultesi ( Site 2202), Eskişehir
Baptist Medical Center/Wolfson Children's Hospital ( Site 2521), Jacksonville
SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 2203), Istanbul
Municipal Institution City Children s Clinical Hospital of Poltava City Council ( Site 2454), Poltava
Hospital Universitario la Fe ( Site 2003), Valencia
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 2452), Dnipro
PI Kryvorizka city clinical hospital 8 ( Site 2458), Kryvyy Rig
Hospital of Lithuanian University of Health Sciences Kaunas ( Site 1001), Kaunas
Universiti Kebangsaan Malaya Medical Centre ( Site 1101), Cheras
University Malaya Medical Centre. ( Site 1100), Kuala Lumpur
Hospital del Nino y Adolescente Morelense ( Site 1204), Emiliano Zapata
St. Louis Children's Hospital ( Site 2511), St Louis
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 1203), Monterrey
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 2461), Ivano-Frankivsk
Primary Children's Hospital ( Site 2500), Salt Lake City
Children's Hospital - Los Angeles ( Site 2508), Los Angeles
Rady Children's Hospital-San Diego ( Site 2505), San Diego
Klaipedos Vaiku Ligonine ( Site 1000), Klaipėda
Children's Hospital of Orange County ( Site 2502), Orange
Seattle Childrens Hospital ( Site 2510), Seattle
Regional Childrens Clinical Hospital ( Site 1809), Vologda
Smolensk Regional Clinical Hospital ( Site 1800), Smolensk
"Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timi ( Site 1701)", Timișoara
Stavropol Regional Pediatric Clinical Hospital ( Site 1805), Stavropol
Spit. Cl. de Urg. Copii Cluj Napoca ( Site 1703), Cluj-Napoca
Chelyabinsk Regional Children Clinical Hospital ( Site 1802), Chelyabinsk
Tufts Medical Center-Floating Hospital for Children ( Site 2516), Boston
Hospital Pequeno Principe ( Site 0200), Curitiba
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0201), Recife
Hospital Tacchini ( Site 0203), Bento Gonçalves
Vaiku Ligonine VU ligonines Santariskiu kliniku filialas ( Site 1002), Vilnius
Instituto Nacional de Pediatria ( Site 1201), Mexico City
Hospital Infantil de Mexico Federico Gomez ( Site 1202), Mexico City
Molotlegi Street ( Site 1901), Pretoria
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 2004), Badalona
Hospital Universitario Sant Joan de Deu ( Site 2000), Esplugues de Llobregat
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 2200), Adana
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2201), Ankara
National Children Specialised Hospital OHMADYT MOH Ukraine ( Site 2459), Kyiv
Merck Sharp & Dohme LLC
INDUSTRY